Using the SPIRIT statement to improve trial protocols

We have updated our instructions for authors to show that we now encourage the use of the SPIRIT statement.

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is ‘an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol’. Its creation was funded by four Canadian health research institutions.

The full statement has been published in the Annals of Internal Medicine, and the explanation and elaboration in the BMJ. BMJ Open’s editor-in-chief, Dr Trish Groves, is a member of the SPIRIT group.

BMJ Open published 17 protocols in 2011 and 79 in 2012, though not all were for interventional trials. We require ethics approval and registration in an ICMJE-approved registry for trial protocols, and encourage registration of systematic review protocols in PROSPERO, led by BMJ Open editorial board member Prof Lesley Stewart.

Publishing protocols provides a valuable service by allowing researchers to publicise ongoing work and hopefully facilitating cooperation and reducing duplicated efforts. By making the intended methods fully available the chances of a study’s replication may be enhanced. Protocol publication should also ensure that any changes to methods adopted during a trial are reported as such in results papers.

As the SPIRIT authors write, ‘High quality protocols facilitate proper conduct, reporting, and external review of clinical trials.’ We will be encouraging authors to use SPIRIT to help meet these goals.

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